Insertion mechanism for drug delivery device

ABSTRACT

An insertion mechanism for a drug delivery device including a trocar, a housing, and a manifold in fluid communication with a fluid pathway connector and movable relative to the housing between a first manifold position adjacent to a proximal end of the housing and a second manifold position adjacent to a distal end of the housing. A hub carrying the trocar or hollow delivery needle is removably connected to the manifold, the hub being movable relative to the housing between a first hub position adjacent to the proximal end of the housing and a second hub position adjacent to the distal end of the housing. A power source is configured to generate rotational motion. A motion conversion mechanism operatively connects the power source and the hub, and is configured to convert the rotational motion into linear motion of the hub.

CROSS-REFERENCE TO RELATED APPLICATION

This is a continuation of U.S. patent application Ser. No. 16/489,833,filed Aug. 29, 2019, which is the U.S. National Stage of PCT/US18/21651,filed Mar. 9, 2018, which claims the benefit of priority of U.S.Provisional Application No. 62/469,226, filed Mar. 9, 2017. The entirecontents of each of the foregoing are incorporated herein by reference.

FIELD OF THE DISCLOSURE

The present disclosure generally relates to drug delivery devices, andmore particularly, mechanisms and methods for inserting a trocar orhollow delivery needle of a drug delivery device into a patient so thata volume of a drug stored in the drug delivery device can be deliveredto the patient.

BACKGROUND

Some drug delivery devices, such as on-body injectors, may betemporarily attached to a patient to deliver a drug via an injectionneedle or some other means over an extended period of time. The drugdelivery device may be attached to the tissue of the patient's abdomen,thigh, arm, or some other portion of the patient's body.

In some cases, the drug delivery device may be worn by the patient forseveral minutes or hours while the drug is injected. For example,viscous drugs, including some biologics, can have long injection timesdue to the force needed to expel them from the drug delivery device.Furthermore, some drug delivery devices are configured to be attached tothe patient at a doctor's office, and then later deliver the drug to thepatient when the patient returns to his or her home. For these reasonsand others, a rigid injection member may be left inside the patient fora substantial amount of time, which can result in patient discomfort orunease.

To address this issue, some drug delivery devices incorporate a cannulamade of a flexible material for delivering the drug to the patient. Sucha cannula can bend to adjust to the patient's body movements andtherefore may be more comfortable than a rigid needle. However, due toits flexibility, the cannula may have difficulty penetrating thepatient's skin during insertion. Therefore, an introducer needle ortrocar is sometimes used to initially penetrate the skin and create apassageway for the cannula. The trocar may be subsequently retracted,leaving the cannula partially inside the patient's body.

The insertion and/or retraction movements of the trocar and/or cannulamay be accomplished by incorporating an insertion mechanism disposedwithin the drug delivery device. Such an insertion mechanism, however,may increase the overall size, complexity, and/or cost of the drugdelivery device.

The present disclosure sets forth insertion mechanisms and relatedmethods embodying advantageous alternatives to existing insertionmechanisms and methods that may address one or more of the challenges orneeds described herein, as well as provide other benefits andadvantages.

SUMMARY

In accordance with a first aspect, a wearable drug delivery device mayinclude a main housing, a container disposed in the main housing, aninsertion mechanism disposed in the main housing, a fluid pathwayconnector defining a sterile fluid flowpath between the container andthe insertion mechanism. The insertion mechanism may include a trocar orhollow delivery needle, an insertion mechanism housing having a proximalend and a distal end. Further, the insertion mechanism may include amanifold in fluid communication with the fluid pathway connector andmovable relative to the insertion mechanism housing between a firstmanifold position adjacent to the proximal end of the insertionmechanism housing and a second manifold position adjacent to the distalend of the insertion mechanism housing. A hub carrying the trocar orhollow delivery needle may be removably connected to the manifold, thehub being movable relative to the insertion mechanism housing between afirst hub position adjacent to the proximal end of the insertionmechanism housing and a second hub position adjacent to the distal endof the insertion mechanism housing. Further, a power source may beconfigured to generate rotational motion, and a motion conversionmechanism may be operatively connecting the power source and the hub,and configured to convert the rotational motion of the power source intolinear motion of the hub.

In accordance with a second aspect, an insertion mechanism may include atrocar or hollow delivery needle, a housing having a proximal end and adistal end. Further, the insertion mechanism may include a manifold andmovable relative to the housing between a first manifold positionadjacent to the proximal end of the housing and a second manifoldposition adjacent to the distal end of the housing. A hub carrying thetrocar or hollow delivery needle may be removably connected to themanifold, the hub being movable relative to the housing between a firsthub position adjacent to the proximal end of the insertion mechanismhousing and a second hub position adjacent to the distal end of thehousing. Further, a power source may be configured to generaterotational motion, and a motion conversion mechanism may be operativelyconnecting the power source and the hub, and configured to convert therotational motion of the power source into linear motion of the hub.

In accordance with a third aspect, a method may include providing awearable drug delivery device comprising a container, a drug disposed inthe container, an insertion mechanism, and a fluid pathway connectordefining a sterile fluid flow path between the container and theinsertion mechanism, the insertion mechanism having an insertionmechanism housing, a hub, a trocar or hollow delivery needle secured tothe hub, a manifold in fluid communication with the fluid pathway andcarried by the hub, a power source configured to generate rotationalmotion, a motion conversion mechanism having a rotating memberoperatively connecting the power source and the hub, and configured toconvert the rotational motion of the power source into linear motion ofthe hub. Next, the method may include disposing the wearable drugdelivery device in contact with a patient's skin and activating thepower source to linearly move the hub, trocar or hollow delivery needle,and manifold in a distal direction so that the trocar or hollow deliveryneedle penetrates the patient's skin. Following, the method includesretracting the trocar or hollow delivery needle from the patient bymoving the hub in the proximal direction. The method may includeexpelling the drug from the container, through the fluid pathwayconnector for subcutaneous delivery to the patient.

In further accordance with any one or more of the foregoing first andsecond aspects and methods, the insertion mechanism for a drug deliverydevice and method may include any one or more of the following forms ormethod steps.

In one form, the insertion mechanism may include a cannula having ahollow interior and being axially aligned with the trocar or hollowdelivery needle. The manifold may be configured to fluidly connect thehollow interior of the cannula and the fluid pathway connector.

In one form, the motion conversion mechanism may include a pin and ayoke, the pin being slidably received in a slot formed in the yoke.

In one form, the pin may be operatively connected to and receivingrotational motion from the power source. Rotation of the pin in a firstrotational direction over a first arc may cause the yoke to movelinearly in a distal direction, and rotation of the pin in the firstrotational direction over a second arc may cause the yoke to movelinearly in a proximal direction.

In one form, the yoke may be rigidly connected to or integrally formedwith the hub such that the hub and yoke move together jointly.

In one form, the motion conversion mechanism may include a guide postextending through an aperture formed in the yoke, the yoke being movablerelative to the guide post.

In one form, the motion conversion mechanism may include a rotatablemember rotatable about a rotational axis by the power source. The pinmay extend from the rotatable member at a position offset from therotational axis.

In one form, the hub may have a first stroke in which the hub initiallymoves from the first hub position to the second hub position to extendthe trocar or hollow needle from the insertion mechanism housing. Thehub may further include a second stroke in which the hub subsequentlymoves from the second hub position to the first hub position to retractthe trocar or hollow needle into the insertion mechanism housing.

In one form, the hub may carry the manifold from the first manifoldposition to the second manifold position during the first stroke.

In one form, the insertion mechanism may include a catch memberconnected to the insertion mechanism housing and configured to engage aproximally facing surface of the manifold when the manifold occupies thesecond manifold position.

In one form, hub may be disconnected from the manifold by the catchmember during the second stroke such that the catch member retains themanifold in the second manifold position while the hub returns to thefirst hub position.

In one form, the catch member may be configured to elastically deform toallow the manifold to move into the second manifold position during thefirst stroke.

In one form, the catch member may include a spring clip initially havingan expanded configuration, the spring clip being compressed by themanifold during the first stroke and subsequently returning to theexpanded configuration once the manifold reaches the second manifoldposition.

In one form, the insertion mechanism may include a lock memberconfigured to selectively engage and prevent rotation of the rotatablemember.

In one form, the rotatable member may have an outer surface including acircular portion and a non-circular portion, the lock member beingconfigured to slide along the circular portion during rotation of therotatable member and prevent further rotation of the rotatable memberwhen the lock member engages the non-circular portion.

In one form of the method, activating the power source may includelinearly moving a cannula secured to the manifold in the distaldirection so that the trocar and cannula penetrate the patient's skin.

In one form of the method, retracting the trocar or hollow deliveryneedle may include disconnecting the hub from the manifold when the hubmoves in the proximal direction to retract the trocar from the patient.

In one form of the method, expelling the drug may include expelling thedrug from the container, through the fluid pathway connector, and intothe cannula for subcutaneous delivery to the patient.

In one form, the method may include activating the motion conversionmechanism, the rotating member of the motion conversion mechanismincluding a yoke and the rotatable member including a pin, the pin beingslidably received in a slot formed in the yoke.

In one form, the method may include rotating the rotatable member andthe pin, the rotatable member operatively connecting the power source,wherein rotation of the rotatable member rotates the pin in a firstrotational direction over a first arc causing the yoke to move linearlyin the distal direction, and wherein rotation of the rotatable memberrotates the pin in the first rotational direction over a second arccausing the yoke to move linearly in the proximal direction.

In one form, the method may include sliding the yoke by the motionconversion mechanism along a guide post, the guide post extendingthrough an aperture formed in the yoke, the yoke being movable relativeto the guide post.

In one form, activating the power source may include moving the hubduring a first stroke from a first hub position adjacent to a proximalend of the insertion mechanism housing to a second hub position adjacentto a distal end of the insertion mechanism housing to extend the trocaror hollow needle from the insertion mechanism housing.

In one form of the method, retracting the trocar or hollow deliveryneedle may include moving the hub during a second stroke from the secondhub position to the first hub position.

In one form, the method may include carrying the manifold by the hubduring the first stroke from a first manifold position adjacent to theproximal end of the insertion mechanism housing to a second manifoldposition adjacent to the distal end of the insertion mechanism housing.

In one form of the method, engaging a proximally facing surface of themanifold by a catch member connected to the insertion mechanism housingwhen the manifold occupies the second manifold position.

In one form of the method, retracting the trocar or hollow deliveryneedle may include disconnecting the hub from the manifold by the catchmember during the second stroke such that the catch member retains themanifold in the second manifold position while the hub returns to thefirst hub position.

In one form of the method, engaging a proximally facing surface of themanifold may include returning the catch member to an initial expandedconfiguration after first deforming as the manifold moves past the catchmember in the distal direction.

In one form of the method, activating the power source may includereleasing an energized torsion spring operatively coupled to therotatable member of the motion conversion mechanism.

In one form, the method may include engaging a portion of the rotatablemember with an obstructing edge to prevent the rotatable member fromrotating.

In one form of the method, engaging the portion of the rotatable membermay include rotating a lock member towards the rotatable member beforethe hub moves in the proximal direction, the lock member having theobstructing edge and being configured to selectively engage and preventrotation of the rotatable member.

In one form of the method, engaging the portion of the rotatable membermay include engaging a non-circular portion of the rotatable member withthe insertion mechanism housing comprising the obstructing edge, thenon-circular portion engaging the obstructing edge after the hub movesin the proximal direction.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed that the disclosure will be more fully understood fromthe following description taken in conjunction with the accompanyingdrawings. Some of the drawings may have been simplified by the omissionof selected elements for the purpose of more clearly showing otherelements. Such omissions of elements in some drawings are notnecessarily indicative of the presence or absence of particular elementsin any of the example embodiments, except as may be explicitlydelineated in the corresponding written description. Also, none of thedrawings is necessarily to scale.

FIG. 1 is a schematic representation of one embodiment of a drugdelivery device having an insertion mechanism in accordance withteachings of the present disclosure.

FIG. 2 is a perspective view of one embodiment of an insertion mechanismin a pre-fired configuration assembled in accordance with teachings ofthe present disclosure.

FIG. 3 is an exploded perspective view of the insertion mechanism ofFIG. 2.

FIG. 4 illustrates a cross-sectional view of the insertion mechanismtaken along line F-F of FIG. 2.

FIG. 5 illustrates the insertion mechanism of FIG. 4 in an insertedconfiguration.

FIG. 6 illustrates the insertion mechanism of FIG. 4 in a retractedconfiguration.

FIG. 7 illustrates a cross-sectional view of a hub, trocar, manifold,cannula, and a fluid pathway connector of the insertion mechanism ofFIGS. 2-6.

FIG. 8 illustrates a cross-sectional view of a fourth exemplaryinsertion mechanism constructed in accordance with the teachings of thepresent disclosure, the insertion mechanism in a pre-firedconfiguration.

FIG. 9 illustrates the insertion mechanism of FIG. 8 in an insertedconfiguration.

FIG. 10 illustrates a partial view of a second exemplary insertionmechanism constructed in accordance with the teachings of the presentdisclosure, the insertion mechanism in an inserted configuration.

FIG. 11 illustrates a hub and cannula guide assembly of the insertionmechanism of FIG. 10.

FIG. 12 illustrates a cross-sectional view of a second exemplary drugdelivery device constructed in accordance with the teachings of thepresent disclosure.

FIG. 13 illustrates a cross-sectional view of a hub, hollow need,cannula guide, cannula, and a fluid pathway connector of a thirdexemplary insertion mechanism of FIG. 12.

FIG. 14 illustrates a fifth exemplary insertion mechanism constructed inaccordance with the teachings of the present disclosure, the insertionmechanism in a pre-loaded configuration.

FIG. 15 illustrates the insertion mechanism of FIG. 14 in a loadedconfiguration.

FIG. 16 illustrates the insertion mechanism of FIG. 14 in a retractedconfiguration.

FIG. 17 illustrates a hub and cannula guide of the insertion mechanismof FIGS. 14-16.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of a drug delivery device 10 accordingto the present disclosure. In at least one embodiment, the drug deliverydevice 10 may be configured as a wearable drug delivery device, such asan on-body injector, that may be attached to a patient's tissue 12(e.g., the patient's skin) to administer delivery of a drug treatment.The drug delivery device 10 may automatically deliver a subcutaneousinjection of a fixed or a patient/operator-settable dose of a drug overa controlled or selected period of time. The drug delivery device 10 maybe intended for self-administration by the patient, but may also be usedby a caregiver or a formally trained healthcare provider to administeran injection.

The drug delivery device 10 may include a container 14, an insertionmechanism 18, a fluid pathway connector 22, a drive mechanism 24, and acontroller 26, each of which may be disposed in a main housing 30 of thedrug delivery device 10. An actuator 28 (e.g., a depressible button) maybe arranged on the exterior of the main housing 30 and configured toinitiate operation of the drug delivery device 10 by activating theinsertion mechanism 18, the drive mechanism 24, and/or the controller 26via mechanical and/or electrical means (shown in dotted lines in FIG.1). The fluid pathway connector 22 defines a sterile fluid flow path 38between the container 14 and the insertion mechanism 18. The fluidpathway connector 22 may include a container access mechanism 29configured to insert a container needle 31 through a septum 32associated with the container 14 to establish fluid communicationbetween the container 14 and the sterile fluid flow path 38 in responseto activation of the drug delivery device 10, for example, via theactuator 28. The main housing 30 may include a bottom wall 36 to bereleasably attached (e.g., adhered with an adhesive) to the patient'sskin 12, and a top wall 40 including one or more indicator lights 42and/or a window (not illustrated) for viewing the container 14. Anopening 44 may be formed in the bottom wall 36, and optionally a septum48 may extend across the opening 44 to seal the interior of the mainhousing 30 prior to use. The exterior of the insertion mechanism 18 maybe defined by an insertion mechanism housing 50 separate from the mainhousing 30.

Upon activation of the drug delivery device 10, the insertion mechanism18 may insert a cannula 34 and/or a trocar (or hollow delivery needle)66 through the opening 44 and septum 48 and into the patient's tissue12. Subsequently, the trocar 66 is removed from the patient's tissue 12and retracts back into the insertion mechanism housing 50 while thecannula 34 remains deployed in the patient's tissue 12. Simultaneouslyor subsequently, the drug delivery device 10 may enable, connect, oropen necessary connections to establish fluid communication between thecontainer 14 and the fluid pathway connector 22. Next, the drivemechanism 24 may force a drug 46 stored in the container 14 through thesterile fluid flow path 38 of the fluid pathway connector 22 and intothe cannula 34 for subcutaneous delivery to the patient.

FIGS. 2-7 illustrate an insertion mechanism 100 corresponding to oneembodiment of the insertion mechanism 18 in FIG. 1. The insertionmechanism 100 may be incorporated in a drug delivery device such as thedrug delivery device 10 depicted in FIG. 1. The insertion mechanism 100includes an insertion mechanism housing 102, a trocar 106, and a cannula110 having a hollow interior 112 which is axially aligned with andinitially surrounding the trocar 106. Further, the insertion mechanism100 includes a cannula guide 114 carrying the cannula 110 and a hub 116carrying the trocar 106. The insertion mechanism 100 has a power source118, a motion conversion mechanism 122 operatively connecting the powersource 118 and the hub 116, and an activation member 170.

The function and operation of the insertion mechanism 100 will bedescribed in three configurations: a pre-fired configuration shown inFIGS. 2 and 4 before the trocar 106 and cannula 110 are deployed; aninserted configuration shown in FIG. 5 where both the trocar 106 andcannula 110 extend through the housing 102 to establish a fluid pathwayfor drug delivery; and a retracted configuration shown in FIG. 6 wherethe trocar 106 is retracted back into the housing 102 and the cannula110 remains extended through the housing and in position for drugdelivery. In FIG. 7, the manifold 114 is in fluid communication with thefluid pathway connector 22, and is configured to fluidly connect thehollow interior 112 of the cannula 110 and the fluid pathway connector22. The cannula guide 114 is movable relative to the housing 102 betweena first cannula guide position adjacent to a proximal end 126 of thehousing 102 shown in FIGS. 2 and 4, and a cannula guide manifoldposition adjacent to a distal end 130 of the housing 102 shown in FIGS.5 and 6. The hub 116 is removably connected to the cannula guide 114 andis movable relative to the housing 102 between a first hub positionadjacent to the proximal end 126 of the housing 102 shown in FIGS. 2, 4and 6, and a second hub position adjacent to the distal end 130 of thehousing 102 shown in FIG. 5. In this example, the cannula guide is amanifold 114.

In some embodiments, the trocar 106 may have a sharpened or beveleddistal tip so that the trocar 106 is capable of piercing the patient'stissue 12 and introducing the cannula 110 inside the patient. The trocar106 may also be referred to as an introducer needle. In someembodiments, the trocar 106 may be solid and thus does not have a hollowcenter. To facilitate this introducing functionality, the trocar 106 maybe made of a more rigid material than the cannula 110. In someembodiments, the trocar 106 may be made of metal, whereas the cannula110 may be made of plastic. Moreover, the relative flexibility of thecannula 110 may render the cannula 110 suitable for being left insidethe patient for several minutes, hours, or days without substantialdiscomfort to the patient. In other embodiments, the trocar 106 andcannula 110 may either be replaced with a hollow delivery needle or justthe trocar 106 may be replaced with a hollow delivery needle disposedwithin the hollow cannula 110.

As shown in FIGS. 2 and 3, the power source 118 of the insertionmechanism 100 may include a torsion spring 134 and the motion conversionmechanism 122 may be a scotch yoke mechanism operatively coupled to thepower source 118. The motion conversion mechanism 122 is configured toconvert the rotational motion of the power source 118 into reciprocatinglinear motion of the hub 116 and manifold 114 to insert the trocar 106and cannula 110 into the patient's tissue 12. Without added obstructionor interference to the power source 118, the motion conversion mechanism122 is capable of continuing to retract the trocar 106 from thepatient's tissue 12 by moving the hub 116 from the second hub positionto the first hub position before completing a full 360 degree rotation.A catch member 138 attached to the housing 102 deforms to permit themanifold 114 to move from the first manifold position (i.e. the firstcannula guide position) to the second manifold position (i.e. the secondcannula guide position). When the manifold 114 occupies the secondmanifold position, the catch member 138 returns to its initial shape toengage the manifold 114 and maintain the cannula 110 deployed while thetrocar 106 is retracted into the housing 102. In a single smoothrotation of a pin 150 of the motion conversion mechanism 122, theinsertion mechanism 100 may insert both the trocar 106 and the cannula110 to establish a drug delivery path and then automatically retract thetrocar 106 without an additional step performed by the patient orhealthcare provider. The smooth rotation of the scotch yoke mechanism122, as will be described in detail below, may provide a smooth andcomfortable insertion method for the patient, leaving only a flexiblecannula inserted for drug delivery.

In FIGS. 2 and 3, the motion conversion mechanism 122 and power source118 are enclosed within the housing 102 of the insertion mechanism 100and between a cover 140 and a base 142. The power source 118 and themotion conversion mechanism 122 may be assembled first to the base 142of the housing 102 before attaching the cover 140 to the base 142 toenclose the systems from the rest of the drug delivery device. In thisembodiment, the cover 140 and the base 142 of the housing 102 aremanufactured separately and then secured together by a plurality offasteners 144 at each corner of the housing 102. The activation member170 is operatively connected to the cover 140 such that the activationmember 170 is externally accessible from the housing 102, and isconfigured to engage the power source 118 within the housing 102 in thepre-fired configuration. The base 142 includes a partition wall 146which separates the motion conversion mechanism 122 and the power source118 into different housing compartments. The partition wall 146 providesa support structure to facilitate assembly and operative connectionbetween the motion conversion mechanism 122 and the power source 118.The power source 118 is operatively connected to the motion conversionmechanism 122 through the partition wall 146, which supports coaxialalignment of the power source 118 and the motion conversion mechanism122 about the rotational axis B. Additionally, the separate compartmentsformed by the partition wall 146 permit the power source 118 and themotion conversion mechanism 122 systems to operate together withoutinterfering with the adjacent system. In case of a sudden movement ofthe insertion mechanism 100 within the drug delivery device, or in caseof component failure, moving parts of each system are held within theirrespective compartments and cannot enter the adjacent compartment andcause further disruption and/or failure. Moreover, assembling the cover140 after the different components are attached to the base 142 issimple, reducing costs associated with complex assembly. In otherembodiments, the housing 102 may be an integrated component without aseparate base and cover components.

In a front compartment of the housing, the motion conversion mechanism122 includes a rotatable member 148, a pin 150 extending from therotatable member 148, a yoke 152, and first and second guide posts 154 aand 154 b. With a uniform speed of rotation of the pin 150 of the motionconversion member 122, a simple harmonic motion of the yoke 152 results,thereby providing a smooth insertion and retraction of the trocar 106.Although hidden in FIGS. 2 and 3, the yoke 152 includes a slot 186 toslidably receive the pin 150. The slot may be either a through-hole or agroove that stops short of extending all the way through the yoke 152.The pin 150 extends from a non-circular portion 160 of the rotatablemember 148 at a position offset from a rotational axis B of therotatable member 148. The yoke 152 includes first and second apertures158 a and 158 b in which each respective guide post 154 a and 154 bextends therethrough. In the illustrated embodiment, the yoke 152 isrigidly connected to or integrally formed with the hub 116 such that thehub 116 and yoke 152 move together jointly as a single unit in thedistal and proximal directions D and E along and parallel to the guideposts 154 a and 154 b.

Through the partition wall, the power source 118 and the rotatablemember 148 are operatively connected. The pin 150 is also operativelyconnected to the power source 118 to receive rotational motion from thepower source 118 via the rotatable member 148. The power source 118includes a mandrel 162, which serves to support the rotatable member 148within the housing 102, keep the rotatable member 148 aligned with therotational axis B, transfer the rotational force of the torsion spring134 to the motion conversion mechanism 122, and hold the torsion spring134 in an energized state when the insertion mechanism 100 is in thepre-fired configuration. At one end, the mandrel 162 may be threadablyconnected to a central portion 164 of the rotatable member 148 by afastener. At an opposing end, the mandrel 162 includes a flange 166having a key slot 168 sized to receive the activation member 170. Themandrel 162 is operatively coupled to the torsion spring 134 such thatthe torsion spring 134 rotates the mandrel 162 when the mandrel 162 isreleased. In the pre-fired configuration, the flange 166 of the mandrel162 is engaged with the activation member 170 to retain the torsionspring 134 in the energized state. After activation, the activationmember 170 disengages from the flange 166 of the mandrel, causing thetorsion spring 134 to rotate the mandrel 152, the pin 150, and therotatable member 148 in direction C about the rotational axis B. Themandrel 162 and the torsion spring 134 may be provided in an energizedpackage to reduce instances of spring release during assembly. Each endmay be fastened to the base 142 of the housing 102 before the motionconversion mechanism 122 is provided. Once the cover 140 is attached tothe base 142, the power source 118 may assume a ready configuration suchthat the activation member 170 can release the power source 118 whenactivated. In other embodiments, the power source 118 may be defined bya pressurized gas mechanism, an electric motor, an elastic membrane, atorsion spring, a leaf spring, and/or any other suitable mechanism forstoring and releasing energy for rotating the components associated withthe motion conversion mechanism 122.

Shown in FIG. 3, the activation member 170 includes a rocker 172, a key174 sized to engage with the key slot 168 of the flange 166, a biasingmember 176, and a pin 178. The pin 178 traverses through a bore 177 inthe rocker 172, a bore in the key 174, and a bore 179 in the cover 140to pivotably connect the rocker 172 and the key 174 to the cover 140.The activation member 170 is disposed within an aperture 180 formed inthe cover 140 of the housing 102, and the biasing member 176 is disposedwithin the cover 140 with a portion extending into the aperture 180.When the insertion mechanism 100 is assembled, the activation member 170is externally accessible from the housing 102 while configured to engageand activate the power source 118 disposed within the housing 102. Inthe pre-fired configuration, the biasing member 176 biases the rocker172 to occupy a first rocker position in which a front portion 182 a ofthe key 174 is moved away from the biasing member 176 and a back portion182 b of the key 174 is disposed through the aperture 180 of the cover140 and disposed within the key slot 168 of the mandrel 166. To activatethe activation member 170, the rocker 172 is pushed so that the rocker172 and the key 174 pivots or rotates about the pin 178 such that thefront portion 182 a of the key 174 pushes against the biasing member 176and the back portion 182 b moves out of contact with the key slot 168 ofthe mandrel 162. Simultaneously or subsequently, the mandrel 162 isreleased and the torsion spring 134 applies a constant torsional load onthe mandrel 162 and rotates the mandrel 162, the pin 150, and therotatable member 148 about the rotational axis B. In some embodiments,the activation member 170 of the insertion mechanism 100 may bemechanically connected to actuator 28 of the drug delivery device 10 ofFIG. 1 such that manual movement of the actuator 28 by a patient orhealthcare provider may activate the insertion mechanism 100. In otherembodiments, movement of the activation member 170 may be accomplishedby an electromechanical feature operated by the controller 26 inresponse to movement of the actuator 28 by the patient or healthcareprovider.

Operation of the insertion mechanism 100 will now be described withreference to the chronological sequence shown in FIGS. 4-6. In thesefigures, the rotatable member 148 is transparent and the power source118 is hidden from view for clarity and to illustrate the movements ofthe insertion mechanism components. Turning first to FIG. 4, the motionconversion mechanism 122 of the insertion mechanism 100 is shown in thepre-fired configuration. The rotatable member 148 is disposed betweenthe cover 140 and the base 142 of the housing 102 and is rotatable in arotational direction C about the rotational axis B extending into thepage. The rotatable member 148 has a non-circular portion 160 with aradius of curvature R₁ extending from the rotational axis B to acenterpoint of the pin 150, and a circular portion 188 with a radius ofcurvature R₂ extending from the rotational axis B to a circumferentialsurface 190 of the rotatable member 148. A pointed tip 185 of thenon-circular portion 160 is in contact with an obstructing edge 194protruding downward from the cover 140 of the housing 102 and disposedin a circumferential path 187 of the pointed tip 185. The pin 150 isdisposed within a slot 186 formed in the yoke 152, where the slot 186 isdefined by a groove extending in a direction perpendicular or otherwisenon-parallel to a longitudinal axis A of the housing 102 from a firstend 196 a to a second end 196 b. In some embodiments, the slot 186 mayhave a linear or substantially linear shape. The pin 150 extends from aposition offset from, and in a direction parallel to, the rotationalaxis B, and is disposed on the non-circular portion 160 of the rotatablemember 148. In the pre-fired configuration, the pin 150 is proximallylocated near the second end 196 b of the slot 186 before moving closerto the second end 196 b as it rotates in rotational direction C. As therotatable member 148 rotates in direction C, the pin 150 rotates aboutrotational axis B along an outer circumferential path 151 defined byradius R₁, causing the yoke 152 to slide in the distal direction E.

Also shown in the pre-fired configuration, the hub 116 is in the firsthub position at the proximal end 126 of the housing 102 and is disposedabove the manifold 114 relative to the cover 140, the manifold 114 beingin the first manifold position. The hub 116 and the manifold 114 may beremovably connected when the hub 116 moves in the distal direction E,keeping the trocar 106 disposed within the hollow interior 112 of thecannula 110 until the hub 116 and the manifold 114 are in theirrespective second positions. The hub 116 and the manifold 114 may beconnected or removably attached by friction, a bonding agent, adhesive,or other suitable mechanical attachment that keeps the manifold 114connected to the hub 116 until the manifold 114 is disconnected from thehub 116 by the catch member 138. The yoke 152 includes two parallelapertures 158 a and 158 b sized to slidably receive first and secondguide posts 154 a and 154 b, and the manifold 114 includes two arcededges 165 a and 165 b sized and shaped to fit around the guide posts 154a and 154 b. During rotation of the rotatable member 148, the first andsecond guide posts 154 a and 154 b may constrain movement of the yoke152 to a linear or substantially linear direction that is parallel orsubstantially parallel to the longitudinal axis A. Between the apertures158 a and 158 b and behind the slot 186 of the yoke 152, the hub 116includes a nose portion 198, which is depicted in FIGS. 2 and 3. Thenose portion 198 is adjacent to, and may be removably attached from, afront portion 200 of the manifold 114. The nose portion 198 has a widthW_(H) and the front portion 200 has a width W_(M) sized so that both thenose portion 198 and the front portion 200 can slide between a space 202defined by the catch member 138. The front portion 200 of the manifold114 is configured to receive the fluid conduit 22 of the drug deliverydevice 10 of FIG. 1.

As shown in FIGS. 2, 3, and 4, the catch member 138 includes first andsecond spring clips 204 a and 204 b attached or otherwise secured to thehousing 102 in the path of the manifold 114. So configured, each springclip 204 a and 204 b deforms when the front portion 200 of the manifold114 passes through the space 202 and subsequently elastically regainsits original shape to lock the manifold 114 in the insertedconfiguration. Each spring clip 204 a and 204 b includes a holed flange206 a and 206 b secured to the housing 102 and an arm 208 a and 208 bdisposed within the housing 102 and expanded outwardly relative to theholed flange 206 a and 206 b. Each flange 206 a and 206 b receives oneof the plurality of fasteners 144, and is secured between the cover 140and the base 142 of the housing 102. Each arm 208 a and 208 b extendsfrom their respective flange 206 a and 206 b, and is bent in a downwardorientation at a joint 210 a and 210 b. Each arm 208 a and 208 b has adistal end 212 a and 212 b extending outwardly from the joint 210 a and210 b, such that the distal ends 212 a and 212 b are inwardly disposedrelative to the longitudinal axis A of the housing 102. The space 202formed by the catch member 138 is defined by a distance between thejoints D_(J) and the distance between the distal ends D_(E) when thespring clip is in its expanded configuration. The catch member 138elastically deforms such that the distance between the distal ends D_(E)increases to be at least equal to the width W_(M) of the front portion200 of the manifold 114, thereby allowing the manifold 114 to move intothe second manifold position. The catch member 138 returns to itsoriginal shape to engage a proximally facing surface 214 of the manifold114 when the manifold 114 occupies the second manifold position. Becausethe width W_(H) of the nose portion 198 of the hub is less than thedistance D_(E) when the catch member 138 is expanded, the nose portion198 slides passed the catch member 138 when the hub 116 returns to thefirst hub position.

In another example shown in FIGS. 10 and 11, a second exemplaryinsertion mechanism 101 may include a different catch member 138 that isconfigured to engage a cannula guide 113 when a hub 117 and the cannulaguide 113 move to the inserted configuration. A motion conversionmechanism 123 includes a yoke 153 and a rotatable member 149, whichcauses the yoke 152, and therefore the hub 117 and cannula guide 113, tomove linearly when the rotatable member 149 is rotated. The cannulaguide 113, which may be similar to the manifold 114, carries the cannula109 and the hub 117 carries a hollow delivery needle 105 to the insertedposition for drug delivery. The cannula guide 113 and the cannula 109remain in the second, or inserted, position as the hub 117 and thehollow delivery needle 105 return back to the first hub position. Thecatch member 138 includes a flexible clip 139 securely attached to abase 143 of the housing 103. As shown in FIG. 11, a shoulder 121extending outwardly from the cannula guide 113 is arranged to deflectthe clip 139 away from the cannula guide 113 as the cannula guide 113moves to the inserted position. Once the cannula guide 113 is in theinserted configuration, the clip 139 snaps into a groove 141 formed inthe shoulder 121 and locks the cannula guide 113 in place as shown inFIG. 10. As such, the clip 139 helps separate the cannula guide 113 fromthe hub 117, allowing the hub 117 and the hollow needle 105 to return tothe initial hub position. In the retracted position, the hollow deliveryneedle 105 fluidly connects a fluid delivery path 125 to the cannula 109to dispense the drug.

Turning now to FIG. 5, the motion conversion mechanism 122 of the firstexemplary insertion mechanism 100 is depicted in the insertedconfiguration. At the end of a first stroke of the hub 116, the hub 116is in the second hub position and the manifold 114 is in the secondmanifold position. The first stroke may be defined as the travel path ofthe hub 116 between the pre-fired configuration and the insertedconfiguration of the insertion mechanism 100. Alternatively, the firststroke may be defined by the length of time from activation of theinsertion mechanism 100 until the insertion mechanism 100 reaches theinserted configuration. During the first stroke, the hub 116 moves fromthe first hub position to the second hub position to extend the trocar106 or hollow needle from the insertion mechanism housing 102.Concurrently, the hub 116 carries the manifold 114 in the distaldirection E from the first manifold position to the second manifoldposition. During the first stroke, the manifold 114 compresses the arms208 a and 208 b of the catch member 138 until the manifold 114 reachesthe second manifold position, at which point the distal ends 212 a and212 b of the catch member 138 return to the expanded configuration. Thepin 150 rotates in a first rotational direction C from its initialposition depicted in FIG. 4 to a position located near the base 142 ofthe housing 102. Following the circumferential path 151 of the pin 150,the pin 150 of the motion conversion mechanism 122 rotates over a firstarc 216, causing the yoke 152 to move linearly in the distal directionE.

In FIG. 6, the motion conversion mechanism 122 of the insertionmechanism 100 is in the retracted configuration. At the end of a secondstroke, the hub 116 is in the first hub position and the manifold 114remains in the second manifold position. The second stroke may bedefined by the travel path of the hub 116 between the insertedconfiguration and the retracted configuration of the insertion mechanism100. Alternatively, the second stroke may be defined by length of timefrom the end of the first stroke and until the insertion mechanism 100reaches the retracted configuration. During the second stroke, the hub116 moves from the second hub position to the first hub position toretract the trocar 106 or hollow needle into the insertion mechanismhousing 102. Also during the second stroke, the catch member 138disconnects the hub 116 from the manifold 114 and retains the manifold114 in the second manifold position while the hub 116 returns to thefirst hub position. Depicted in FIG. 6, the distal ends 212 a and 212 bof the catch member 138 are disposed between the proximally facingsurface 214 of the manifold 114. The pin 150 of the motion conversionmechanism 122 rotates in the first rotational direction C over a secondarc 218 of the circumferential path 216, causing the yoke 152 to movelinearly in the proximal direction D.

Shown in FIG. 7, the fluid pathway connector 22 and the cannula 110 areconnected to the manifold 114 such that the cannula 110 and the fluidpathway connector 22 can move relative to the housing 102 when theinsertion mechanism 100 is activated. The fluid pathway connector 22includes a flexible fluid conduit 218 in fluid communication with aninternal chamber 220 of the manifold 114. The flexible fluid conduit 218may define a portion, or the entirety, of the sterile fluid flow path 38depicted in FIG. 1. As shown in FIG. 2, a vertical channel or opening222 defined by the cover 140 and the base 142 permits the fluid pathwayconnector 22 and flexible fluid conduit 218 to move relative to thehousing 102 when the manifold 114 moves between the first manifoldposition and the second manifold position. The manifold 114 includes aseptum 224 disposed in the internal chamber 220 of the manifold 114. Thetrocar 106 is disposed through the septum 224 when the insertionmechanism 100 is both in the pre-fired and inserted configurations. Asthe trocar 106 returns with the hub 116 to the first hub position, thetrocar 106 moves in the proximal direction D relative to the housing102, thereby passing through the internal chamber 220, the septum 224,and an opening 226 in the proximally facing surface 214 of the manifold114. The septum 224 seals the opening 226 closed so that fluid cannotescape through the opening 226 during drug delivery. In someembodiments, the trocar 106 may retract from the internal chamber 220when the manifold 114 and cannula 110 are arranged in the secondmanifold position so that the trocar 106 is isolated from the sterilefluid flow path 38 during drug delivery. In other embodiments, theinsertion mechanism 100 may not include a cannula 110 and insteadincludes a hollow delivery needle in fluid communication with the fluidpathway connector 22 via the manifold 114. In this case, the hollowdelivery needle is a rigid material capable of piercing a patient'stissue 12 that remains inside the patient until drug delivery iscomplete. As the hollow delivery needle acts as both an introducer and adrug delivery conduit for the insertion mechanism 100, the manifold andthe hub may be integrally formed. In another embodiment, the insertionmechanism 100 may be more compact to permit the trocar 106 to retractinto the septum 224, the opening 226, and be sufficiently removed fromthe internal chamber 220 to permit fluid flow.

In a second exemplary drug delivery device 11 shown in FIG. 12, acontainer holding a drug (not shown), a third exemplary insertionmechanism 19, a fluid pathway connector 23, a drive mechanism 25, and acontroller are disposed in a main housing 31 of the drug delivery device11. An actuator (e.g., a depressible button) may be arranged on theexterior of the main housing 31 and configured to initiate operation ofthe drug delivery device 11 by activating the insertion mechanism 19,the drive mechanism 25, and/or the controller via mechanical and/orelectrical means. The fluid pathway connector 23 defines a sterile fluidflow path 39 between the container and the insertion mechanism 19. Thefluid pathway connector 23 may include a container access mechanism (notillustrated) configured to insert a container needle through a septumassociated with the container to establish fluid communication betweenthe container and the sterile fluid flow path 39 in response toactivation of the drug delivery device 11, for example, via theactuator. The main housing 31 may include a bottom wall 37 to bereleasably attached (e.g., adhered with an adhesive) to the patient'sskin, and a top wall 41 including one or more indicator lights and/or awindow (not illustrated) for viewing the container. An opening 45 may beformed in the bottom wall 37. The insertion mechanism 19 includes amotion conversion mechanism 21 may be configured to operate similarly tothe motion conversion mechanism 122 of the first exemplary insertionmechanism 100.

By comparison to the first exemplary insertion mechanism 100, the thirdexemplary insertion mechanism 19 of FIGS. 12 and 13 include a hollowneedle 107 that is fluidly connected to the fluid pathway connector 23.In this case, the insertion mechanism 19 does not include a manifold 114for fluid connection to a container containing a drug. Instead, a fluidpath 219 is directly connected to a barbed end 127 of the hollow needle107, as shown in FIG. 13, and the hollow needle 107 is configured todispense a drug into a cannula 111 for drug delivery. In operation, acannula guide 115, which may be similar to the manifold 114, carries thecannula 111 to the second position with a hub 119 for drug delivery, andremains in the second position when the hub 119 returns to the first hubposition. When the hub 119 is retracted back to the the first hubposition, a drug may be expelled from the container, through the fluidpathway connector 23 and fluid path 219, into the hollow needle 107 andfinally into the cannula 111 for delivery to a patient. A seal 225, suchas an O-ring, is disposed around an outer diameter of the hollow needle107 in the cannula guide 115 to provide a sealed pathway for fluiddelivery. The cannula guide 115 may be removably connected to the hub119, like the manifold 114, or the cannula guide 115 may be removablyconnected to the hub 119 by another mechanism.

In FIGS. 8 and 9, a fourth exemplary insertion mechanism 300 isillustrated in accordance with another embodiment of the presentdisclosure. The fourth exemplary insertion mechanism 300 is similar tothe first exemplary insertion mechanism 100 described above, except forthe configuration of the motion conversion mechanism 322. Additionally,the insertion mechanism 300 of the present embodiment does not have acannula, but instead the introducer is a hollow delivery needle 306.Other elements of the insertion mechanism 300 in FIGS. 8 and 9 which aresimilar to the elements of the insertion mechanism 100 are designated bythe same reference numeral, incremented by 200. A description of many ofthese elements is abbreviated or even eliminated in the interest ofbrevity. Further, the insertion mechanism 300 may be incorporated into adrug delivery device such as the drug delivery device 10 depicted inFIG. 1 or the drug delivery device 11 depicted in FIG. 12.

The insertion mechanism 300 is illustrated in FIGS. 8 and 9 from asimilar perspective as the cross-sectional view F-F of the insertionmechanism 100 in FIG. 2. Here, the manifold 314 and the hub 316 arefixedly attached so that they may not disconnect when the hub 316 movesin the proximal direction D to retract the hollow delivery needle 306during the second stroke. Rather, the hub 316 and the manifold 314 maybe integrally formed with the yoke 352 so that the yoke 352, manifold314, and hub 316 move together jointly as a single unit between thepre-fired, the inserted, and the retracted configurations. In thepre-fired configuration, the pin 350 is disposed within the slot 386 ofthe yoke 352 at the proximal end 326 of the housing 302. During thefirst stroke over the first arc 416 of the pin 350, the hub 316 carriesthe manifold 314 so that the manifold moves from the first manifoldposition in FIG. 8 to the second manifold position in FIG. 9. Similarly,the hub 316 and the yoke 352 slide in the distal direction E from thefirst hub position to the second hub position, inserting the hollowdelivery needle 306 through the distal end 330 of the housing 302.

Simultaneously or subsequently, a spring-biased lock member 500 havingan obstructing edge 494 engages with the non-circular portion 360 of therotatable member 348. The non-circular portion 360 of this embodimentincludes an angled indentation 506 forming an abrupt corner 504 in thecircumferential surface 390 of the rotatable member 348. The angledindentation 506 is shaped to guide the obstructing edge 494 of thespring-biased lock member 500 into the corner 504 so that theobstructing edge 494 eventually stops the rotatable member 348 fromrotating when the pin 350 moves over the first arc 416. As the pin 350rotates in the circumferential path 351, the obstructing edge 494 of thespring-biased lock member 500 slides against the circumferential surface390 of the circular-portion 388 of rotatable member 348. Thespring-biased lock member 500 may be slightly biased in the proximaldirection E so that it rotates inwardly toward the rotatable member 348to make continuous contact with a circular portion 361 of thecircumferential surface 390 during the first stroke. As the non-circularportion 360 of the rotatable member 348 contacts the obstructing edge494, the lock member 500 moves inwardly toward the rotatable member 348until the obstructing edge 494 catches the corner 504 preventing furtherrotation of the rotatable member 348. The first stroke may end once theobstructing edge 494 catches the corner 504 of the non-circular portion360.

In the inserted configuration in FIG. 9, the pin 350 is at the distalend 330 of the housing after moving over the first arc 416. The manifold314 may be in fluid communication with the fluid pathway connector 22,and is configured to fluidly connect the hollow interior 312 of thehollow delivery needle 306 and the fluid pathway connector 22. When thespring-biased lock member 500 has engaged the rotatable member 348, thecontainer access mechanism 29 may be activated to being fluid deliverythrough the hollow delivery needle 306. When drug delivery is complete,the lock member 500 may be biased in the distal direction E to disengagethe obstructing edge 494 from the corner 504 of the non-circular portion360, permitting the pin 350 to continue rotation in the C direction overarc 418. After drug delivery is complete and during the second stroke,the pin 350 moves over the second arc 418 to retract the hollow deliveryneedle 306 into the housing 302. In another embodiment, the hub 316 andthe manifold 314 may be disconnected when the hub 316 moves in theproximal direction D by the catch member 338. In this case, the powersource 318 and the motion conversion mechanism 322 are configured toprevent the hub 316 carrying the hollow delivery needle 306 from movingback in the proximal direction E.

In the disclosed embodiments, the displacement of the yoke 152 and 352is a function of the pin 150 and 350 position. That is, at maximum depthof the trocar 106 or hollow delivery needle 306, the pin is rotated toits lowest position. The torsion spring 134 and 334 may be provided suchthat it supplies a torque that is greater than or equal to the systemtorque for all positions of the pin 150 and 350, from 0-360 degrees. Ina case where the pin 150 and 350 rotates 360 degrees, a torsion springhaving a deflection angle of 360 degrees may be provided. To maintainspring torque in during the second stroke, the spring angular positionwill need to be offset with respect to the position of the pin 150 and350. So configured, when the pin 150 and 350 reaches the final positionat the 360 degrees mark, the spring 134 and 334 still supplies torque.In a preferred embodiment the angular start position of the pin is 20degrees, the radius R₁ of the pin is 5.16 mm, the mass of the movingmanifold 114 and hub 116 is 0.286 g, the torsion spring rate of thetorsion spring 134 is 0.096 N-m/degree, and the max torque at 360degrees is 34.7 N-m to achieve a 0.01 s insertion time, 8 mm injectiondepth, and 25 mm device height.

In FIGS. 14-16, a fifth exemplary insertion mechanism 600 is constructedin accordance with the teachings of the present disclosure. The fifthexemplary insertion mechanism 600 is similar to the fourth exemplaryinsertion mechanism 300 described above, except for the operation of arotatable member 648 of a motion conversion mechanism 622. The insertionmechanism 600 also differs from the fourth exemplary insertion mechanism300 by including a hollow delivery needle 606, a cannula 610, and acannula guide 614 for fluid delivery. Other elements of the fifthexemplary insertion mechanism 600 in FIGS. 14-16 which are similar tothe elements of the fourth exemplary insertion mechanism 300 aredesignated by the same reference numeral, incremented by 300. Adescription of many of these elements is abbreviated or even eliminatedin the interest of brevity. Further, the insertion mechanism 600 may beincorporated into a drug delivery device such as the drug deliverydevice 10 depicted in FIG. 1 or the drug delivery device 11 depicted inFIG. 12.

The insertion mechanism 600 provides a cannula guide 614 and a hub 616that are removably attached so that they may disconnect when the hub 616moves in the proximal direction D to retract the hollow delivery needle606. In FIG. 14, the motion conversion mechanism 622 is shown in apre-loaded configuration, and a rotatable member 648 is rotated in adirection G to load the cannula 610. A stop block 651 is configured tomove within a semi-circular groove (not illustrated) formed in thehousing 602, and slides relative to a surface of the rotatable member648. The stop block 651 is in a first position in FIG. 14 such that atrailing end 631 is abutting against an internal wall of the housing 602so that the stop block 651 cannot rotate further in the G direction. Assuch, when the insertion mechanism 600 is being loaded and the rotatablemember 648 is rotated in the G direction, a leading end 633 of the stopblock 651 abuts against a trailing edge 635 of the rotatable member 648to stop the rotatable member 648 from further rotating in the Gdirection. In the loaded configuration shown in FIG. 15, a trigger (notillustrated, but similar to the trigger 500 of FIGS. 8 and 9) holds acorner 804 of the rotatable member 538 prior to activation. In thisconfiguration, the trailing edge 635 of the rotatable member is spacedaway from the leading end 633 of the stop block 651.

When the trigger releases the rotatable member 648, the rotatable member648 rotates in the H direction and moves relatively to the stop block651 until a leading edge 637 of the rotatable member 648 contacts atrailing end 631 of the stop block 661. When the leading edge 637contacts the stop block 651, the rotatable member 648 carries the stopblock 651 in rotation in the H direction until a protruding portion ofthe leading end 633 of the stop block 651 contacts an internal wall (notillustrated) of the housing 602, preventing the rotatable member 648from further rotating in the H direction. The internal walls of housing,which define the travel path of the stop block 651, are sized to engagewith the protruding portion of the stop block 651, but do not engagewith the rotatable member 648 as the rotatable member 648 rotates. InFIG. 16, the rotatable member 648 has completed a 360 degree rotation inthe H direction, or has completed first and second strokes withoutpausing between the first and second strokes. At the end of the secondstroke, the protruding portion of the leading end 633 of the stop block651 and the internal wall of the housing 602 are engaged to prevent therotatable member 648 from rotating further in the H direction.

The motion conversion mechanism 622 may convert rotational motion of therotatable member 648 to linear motion of the hub 616 and cannula guide614 via a scotch yoke mechanism. While not illustrated, the rotatablemember 648 may include a pin or other coupling member that engages in aslot 686 of a yoke 652 in a similar manner as the scotch yoke mechanismof the motion conversion mechanism 322 of FIGS. 8 and 9. In contrast tothe motion conversion mechanism 322 of FIGS. 8 and 9, the motionconversion mechanism 622 of the insertion mechanism 600 of FIGS. 14-16permits the rotatable member 648 to complete at least a full 360 degreerotation, i.e. first and second strokes, to insert the cannula 610 andhollow delivery needle 606 into the patient and retract the hollowdelivery needle 606 back to its second hub position. During the firststroke of approximately a 180 degree rotation, the hub 616 and thecannula guide 614 move together as a unit in the distal direction E toinsert the hollow needle (not illustrated) and the cannula 610 into apatient. At a midpoint of the rotation, i.e. at the end of the firststroke, the hub 616 is in the second hub position and the cannula guide614 is in the second cannula guide position (not shown). Without therotatable member 648 pausing, the hub 616 and cannula guide 614 separateso that the cannula guide 614 remains in the second cannula guideposition while the hub 616 continues in the proximal direction D toreturn to the first hub position. This example allows for a more compactdesign, and may be configured to operate with cannulas 610 and hollowneedles 606 of many different lengths. The distance the cannula 610 andhollow needle 606 can travel into a patient may be governed by thediameter of a drum of the rotatable member 648 and the position of thepin.

In FIG. 17, the cannula guide 614 and the hub 616 are in the pre-firedconfiguration. In this example, the cannula guide 614 includes first andsecond deformable arms 649, 651 that are guided by first and secondsides 655, 657 of a track 659 formed in the housing 602. As the cannulaguide 614 moves from the first cannula guide position to the secondcannula guide position, the deformable arms 649, 653 slide against thefirst and second sides 655, 657 of the track 659, respectively, whichcause each arm 649, 653 to bend inwardly as the cannula guide 614 movesin the distal direction E. At or before the point of cannula insertion,the deformable arms 649, 653 flex outwardly at a bend 661, 663 in eachside 655, 657 of the track 659. Each bend 661, 663 engages the arm 649,653 of the cannula guide 614 to prevent the cannula guide 614 frommoving in the proximal direction D when the hub 616 returns to theinitial hub position. In this example, the track 659 protrudes outwardlyfrom a flat surface of the housing 602, however in other examples, thetrack 659 may be a groove that receives a portion of each arm 649, 653of the cannula guide 614.

When the hub 616 returns to the first hub position, the hollow needle606 is in position to deliver the drug to the cannula 610 which remainsinserted in the patient. The insertion mechanism 600 may deliver drug toa patient in the same or similar manner as described and illustratedabove with reference to FIG. 13.

Described below is an embodiment of a method of operating a drugdelivery device, such as the drug delivery device illustrated in FIG. 1and the drug delivery device 11 of FIG. 12, incorporating the insertionmechanism 100, 101, 19, 300, and 600 shown in FIGS. 2-7, 10 and 11, 12and 13, 8 and 9, and 14-17. The method may begin with providing apatient or a healthcare provider (e.g., a caregiver, nurse, doctor,etc.) with the wearable drug delivery device 10, 11. Next, the patientor healthcare provider may dispose the bottom wall 36, 37 of the drugdelivery device 10, 11 in contact with the patient's tissue 12 to adhereor otherwise temporarily attach the bottom wall 36, 37 of the drugdelivery device 10, 11 to the patient's skin 12. To activate theinsertion mechanism 100, 101, 19, 300, and 600, the patient orhealthcare provider may depress the actuator 28, which in turn maydisplace the activation member 170 such that the activation member 170disengages or releases the power source 118. As a result, the torsionspring 134 of the power source 118 is released, providing rotationalmotion to the motion conversion mechanism 122, 123, 21, 322, and 622.The rotational motion is converted by the motion conversion mechanism122, 123, 21, 322, and 622 to linearly move the hub 116, 117, 119, 316,and 616 the trocar 106 or hollow delivery needle 105, 107, 306, 606 andthe manifold 114 or cannula guide 113, 115, 614 in a distal direction Eso that the trocar 106 or hollow delivery needle 105, 107, 306, 606penetrates the patient's skin.

The method may include activating the motion conversion mechanism 122,123, 21, 322, and 622 by rotating the rotating member 148, 149, 348, and648 operatively coupled to the power source. By rotating the rotatingmember 148, 149, 348, and 648 in the rotational direction C or H, thepin 150 and 350 slidably received in the slot 186, 386, and 686 formedin the yoke 152, 153, 352, and 652 rotates over the first arc 216 and416 or 180 degrees causing the yoke 152 and 352 to move linearly in thedistal direction E. Continued rotation of the rotatable member 148, 149,348, and 648 in the rotational direction C rotates the pin 150 and 350over the second arc 218 and 418 or another 180 degrees causing the yoke152, 153, 352, and 652 to move linearly in the proximal direction D andretract the trocar 106 or hollow delivery needle 105, 107, 306, 606.

In another embodiment, the hollow delivery needle 306 may remain in thepatient and the hub 316 and manifold 314 may remain at the distal end ofthe housing 302 until fluid delivery is completed. Subsequent to orconcurrently with insertion of the hollow delivery needle 306, themethod may include: (a) activating the container access mechanism 29 toinsert the container needle 31 through the septum 32 to establish fluidcommunication between the container 14 and the sterile fluid flow path18 of the fluid connector 22; and (b) activating the drive mechanism 24to expel the drug 46 from the container 14 through the fluid pathwayconnector 22, and into the hollow delivery 306 for delivery to thepatient.

In a different embodiment, the hollow cannula 110 may also be insertedinto the patient's tissue 12 to introduce delivery path. Subsequently,the hub 116 may be disconnected from the manifold 114 to retain thecannula 110 inserted in the patient's tissue 12 and the trocar 106 maybe retracted from the patient by moving the hub 116 in the proximaldirection D. Subsequent to, or concurrently with, insertion of thecannula 110, the method may include: (a) activating the container accessmechanism 29 to insert the container needle 31 through the septum 32 toestablish fluid communication between the container 14 and the sterilefluid flow path 18 of the fluid connector 22; and (b) activating thedrive mechanism 24 to expel the drug 46 from the container 14 throughthe fluid pathway connector 22, and into the cannula 110 for delivery tothe patient. In some embodiments, activating the insertion mechanism 54,the container access mechanism 29, and/or the drive mechanism 24 may beaccomplished through a single depression of the actuator 28. Todisconnect the hub 116 and the manifold 114, the catch member 138engages the proximally facing surface 214 of the manifold 114, retainingthe manifold 114 in the second manifold position while the hub 116returns to the first hub position 116.

In yet another example, the hollow cannula 109, 111, and 610 may remainin the patient, the cannula guide 113, 115, 614 may remain at the distalend of the housing, and the hub 117, 119, and 616 and hollow deliveryneedle 105, 107, 306, 606 may return to the first hub position. In thisposition, the hollow delivery needle 105, 107, 306, 606 is in fluidconnection with the cannula 109, 111, 610. The method may include (a)activating the container access mechanism to insert the container needlethrough the septum to establish fluid communication between thecontainer and the sterile fluid flow path 19 of the fluid connector 23;and (b) activating the drive mechanism 25 to expel the drug from thecontainer through the fluid pathway connector 23, and into the cannula109, 111, 610 for delivery to the patient.

The method may include engaging the rotatable member 148, 149 and 348with an obstructing edge 194 and 494 to prevent the rotatable 148, 149,and 348 member from rotating. In one case, engaging the rotatable member148, 149, and 348 includes rotating the spring-biased lock member 500having the obstructing edge 494 towards the rotatable member 148, 149,and 348 to engage with the non-circular portion 160 and 360 of therotatable member 148, 149, and 348. In another embodiment, the housing102 may include the obstructing edge 194 and 494 configured to engagewith the non-circular portion 160 and 360 of the rotatable member 148and 348 and stop the rotatable member 148, 149, and 348 from continualrotation. In another example, the rotatable member 648 may be activatedand may engage with the stop block 651 to stop the rotatable member 648from continual rotation.

The methods and mechanisms described herein provide advantages overknown insertion devices, such as simpler design, increased reliability,decrease in patient discomfort and anxiety, increase in accuracy, anddecrease in terms of costs and time of manufacturing. Furthermore, theinsertion mechanisms 100, 101, 19, 300, and 600 of the presentdisclosure may be easily adapted for use with many different wearabledrug delivery devices and may be customized for specific patientpopulations. The insertion mechanisms 100, 101, 19, 300, and 600 may beimplemented in a wide variety of wearable drug delivery devicesconfigured with various drive mechanisms, having various forms andsizes, and including various drugs. The operation of the insertionmechanisms 100, 101, 19, 300, and 600, and particularly the powersources 118 and the motion conversion mechanism 122, 123, 21, 322, and622 are not limited in operation or function by the drive mechanism 24,25, the activation mechanism 170 or 270 or the form of the drug deliverydevice 10, 11. Further, the insertion mechanisms 100, 101, 19, 300, and600 may be adapted or customized to minimize pain for specific patientsand patient populations. For example, the travel distance between thepre-fired configuration and the inserted configuration of the manifolds114 and 314, cannula guides 113, 115, 614, and the hubs 116, 117, 119,316 may be minimized. The mass of the manifolds 114 and 314 and cannulaguides 113, 115, 614 may be decreased to lessen the insertion impactforce imparted onto the patient.

The insertion mechanisms 100, 101, 19, 300, and 600 may also increasepatient comfort and decrease potential patient anxiety. For example, theinsertion mechanism 100 may automatically operate and the hub 116 may beconfigured to immediately retract the trocar 106 upon insertion of thecannula 110 in the patient, minimizing time the trocar 106 is disposedin the patient's body. In conventional methods and mechanisms, patientsmay be required to insert the trocar or rigid needle into themselves asthey advance a button into the device. This type of insertion mechanismmay be a cause of anxiety or intimidation to the patient because theyare controlling the insertion of the trocar with the advancement of thebutton. Additionally, known methods and mechanisms include rigid needlescombined with an external safety guard that may remain in the patient'sskin when the patient is removing the wearable device. In contrast, thedisclosed wearable drug delivery device may have a smaller injectionsite and can be configured to retract the trocar 106 or hollow deliveryneedle 306 before the patient removes the wearable device.

The motion conversion mechanism 322 of the insertion mechanism 300 ofFIGS. 8 and 9 and the motion conversion mechanism 622 beneficiallyprovides a simpler operation with fewer moving parts, a reduced numberof components, and a compact design. For example, the insertionmechanism 300 requires fewer parts as the housing 302 is simpler, thehub 316, manifold 314, and yoke 352 form a unified component, and theinsertion mechanism 300 does not require a cannula. With fewercomponents and a simpler design, the provided insertion mechanism 300may have reduced manufacturing and assembly costs. However, the scope ofthe present disclosure is not limited to these or any other benefits andadvantages described herein, and other benefits and advantages mayresult from the disclosed embodiments and any modifications thereto inaccordance with principles of the present disclosure.

Drug Information

The above description describes various systems and methods for use witha drug delivery device. It should be clear that the system, drugdelivery device or methods can further comprise use of a medicamentlisted below with the caveat that the following list should neither beconsidered to be all inclusive nor limiting. The medicament will becontained in a reservoir. In some instances, the reservoir is a primarycontainer that is either filled or pre-filled for treatment with themedicament. The primary container can be a cartridge or a pre-filledsyringe.

For example, the drug delivery device or more specifically the reservoirof the device may be filled with colony stimulating factors, such asgranulocyte colony-stimulating factor (G-CSF). Such G-CSF agentsinclude, but are not limited to, Neupogen® (filgrastim) and Neulasta®(pegfilgrastim). In various other embodiments, the drug delivery devicemay be used with various pharmaceutical products, such as anerythropoiesis stimulating agent (ESA), which may be in a liquid or alyophilized form. An ESA is any molecule that stimulates erythropoiesis,such as Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo®(epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta),Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon®(epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa),epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta),Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa,epoetin beta, epoetin zeta, epoetin theta, and epoetin delta, as well asthe molecules or variants or analogs thereof as disclosed in thefollowing patents or patent applications, each of which is hereinincorporated by reference in its entirety: U.S. Pat. Nos. 4,703,008;5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078;5,773,569; 5,955,422; 5,986,047; 6,583,272; 7,084,245; and 7,271,689;and PCT Publication Nos. WO 91/05867; WO 95/05465; WO 96/40772; WO00/24893; WO 01/81405; and WO 2007/136752.

An ESA can be an erythropoiesis stimulating protein. As used herein,“erythropoiesis stimulating protein” means any protein that directly orindirectly causes activation of the erythropoietin receptor, forexample, by binding to and causing dimerization of the receptor.Erythropoiesis stimulating proteins include erythropoietin and variants,analogs, or derivatives thereof that bind to and activate erythropoietinreceptor; antibodies that bind to erythropoietin receptor and activatethe receptor; or peptides that bind to and activate erythropoietinreceptor. Erythropoiesis stimulating proteins include, but are notlimited to, epoetin alfa, epoetin beta, epoetin delta, epoetin omega,epoetin iota, epoetin zeta, and analogs thereof, pegylatederythropoietin, carbamylated erythropoietin, mimetic peptides (includingEMP1/hematide), and mimetic antibodies. Exemplary erythropoiesisstimulating proteins include erythropoietin, darbepoetin, erythropoietinagonist variants, and peptides or antibodies that bind and activateerythropoietin receptor (and include compounds reported in U.S.Publication Nos. 2003/0215444 and 2006/0040858, the disclosures of eachof which is incorporated herein by reference in its entirety) as well aserythropoietin molecules or variants or analogs thereof as disclosed inthe following patents or patent applications, which are each hereinincorporated by reference in its entirety: U.S. Pat. Nos. 4,703,008;5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078;5,773,569; 5,955,422; 5,830,851; 5,856,298; 5,986,047; 6,030,086;6,310,078; 6,391,633; 6,583,272; 6,586,398; 6,900,292; 6,750,369;7,030,226; 7,084,245; and 7,217,689; U.S. Publication Nos. 2002/0155998;2003/0077753; 2003/0082749; 2003/0143202; 2004/0009902; 2004/0071694;2004/0091961; 2004/0143857; 2004/0157293; 2004/0175379; 2004/0175824;2004/0229318; 2004/0248815; 2004/0266690; 2005/0019914; 2005/0026834;2005/0096461; 2005/0107297; 2005/0107591; 2005/0124045; 2005/0124564;2005/0137329; 2005/0142642; 2005/0143292; 2005/0153879; 2005/0158822;2005/0158832; 2005/0170457; 2005/0181359; 2005/0181482; 2005/0192211;2005/0202538; 2005/0227289; 2005/0244409; 2006/0088906; and2006/0111279; and PCT Publication Nos. WO 91/05867; WO 95/05465; WO99/66054; WO 00/24893; WO 01/81405; WO 00/61637; WO 01/36489; WO02/014356; WO 02/19963; WO 02/20034; WO 02/49673; WO 02/085940; WO03/029291; WO 2003/055526; WO 2003/084477; WO 2003/094858; WO2004/002417; WO 2004/002424; WO 2004/009627; WO 2004/024761; WO2004/033651; WO 2004/035603; WO 2004/043382; WO 2004/101600; WO2004/101606; WO 2004/101611; WO 2004/106373; WO 2004/018667; WO2005/001025; WO 2005/001136; WO 2005/021579; WO 2005/025606; WO2005/032460; WO 2005/051327; WO 2005/063808; WO 2005/063809; WO2005/070451; WO 2005/081687; WO 2005/084711; WO 2005/103076; WO2005/100403; WO 2005/092369; WO 2006/50959; WO 2006/02646; and WO2006/29094.

Examples of other pharmaceutical products for use with the device mayinclude, but are not limited to, antibodies such as Vectibix®(panitumumab), Xgeva™ (denosumab) and Prolia™ (denosamab); otherbiological agents such as Enbrel® (etanercept, TNF-receptor/Fc fusionprotein, TNF blocker), Neulasta® (pegfilgrastim, pegylated filgastrim,pegylated G-CSF, pegylated hu-Met-G-CSF), Neupogen® (filgrastim, G-CSF,hu-MetG-CSF), and Nplate® (romiplostim); small molecule drugs such asSensipar® (cinacalcet). The device may also be used with a therapeuticantibody, a polypeptide, a protein or other chemical, such as an iron,for example, ferumoxytol, iron dextrans, ferric glyconate, and ironsucrose. The pharmaceutical product may be in liquid form, orreconstituted from lyophilized form.

Among particular illustrative proteins are the specific proteins setforth below, including fusions, fragments, analogs, variants orderivatives thereof:

OPGL specific antibodies, peptibodies, and related proteins, and thelike (also referred to as RANKL specific antibodies, peptibodies and thelike), including fully humanized and human OPGL specific antibodies,particularly fully humanized monoclonal antibodies, including but notlimited to the antibodies described in PCT Publication No. WO 03/002713,which is incorporated herein in its entirety as to OPGL specificantibodies and antibody related proteins, particularly those having thesequences set forth therein, particularly, but not limited to, thosedenoted therein: 9H7; 18B2; 2D8; 2E11; 16E1; and 22B3, including theOPGL specific antibodies having either the light chain of SEQ ID NO:2 asset forth therein in FIG. 2 and/or the heavy chain of SEQ ID NO:4, asset forth therein in FIG. 4, each of which is individually andspecifically incorporated by reference herein in its entirety fully asdisclosed in the foregoing publication;

Myostatin binding proteins, peptibodies, and related proteins, and thelike, including myostatin specific peptibodies, particularly thosedescribed in U.S. Publication No. 2004/0181033 and PCT Publication No.WO 2004/058988, which are incorporated by reference herein in theirentirety particularly in parts pertinent to myostatin specificpeptibodies, including but not limited to peptibodies of the mTN8-19family, including those of SEQ ID NOS:305-351, including TN8-19-1through TN8-19-40, TN8-19 con1 and TN8-19 con2; peptibodies of the mL2family of SEQ ID NOS:357-383; the mL15 family of SEQ ID NOS:384-409; themL17 family of SEQ ID NOS:410-438; the mL20 family of SEQ IDNOS:439-446; the mL21 family of SEQ ID NOS:447-452; the mL24 family ofSEQ ID NOS:453-454; and those of SEQ ID NOS:615-631, each of which isindividually and specifically incorporated by reference herein in theirentirety fully as disclosed in the foregoing publication;

IL-4 receptor specific antibodies, peptibodies, and related proteins,and the like, particularly those that inhibit activities mediated bybinding of IL-4 and/or IL-13 to the receptor, including those describedin PCT Publication No. WO 2005/047331 or PCT Application No.PCT/US2004/37242 and in U.S. Publication No. 2005/112694, which areincorporated herein by reference in their entirety particularly in partspertinent to IL-4 receptor specific antibodies, particularly suchantibodies as are described therein, particularly, and withoutlimitation, those designated therein: L1H1; L1H2; L1H3; L1H4; L1H5;L1H6; L1H7; L1H8; L1H9; L1H10; L1H11; L2H1; L2H2; L2H3; L2H4; L2H5;L2H6; L2H7; L2H8; L2H9; L2H10; L2H11; L2H12; L2H13; L2H14; L3H1; L4H1;L5H1; L6H1, each of which is individually and specifically incorporatedby reference herein in its entirety fully as disclosed in the foregoingpublication;

Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies,and related proteins, and the like, including but not limited to thosedescribed in U.S. Publication No. 2004/097712, which is incorporatedherein by reference in its entirety in parts pertinent to IL1-R1specific binding proteins, monoclonal antibodies in particular,especially, without limitation, those designated therein: 15CA, 26F5,27F2, 24E12, and 10H7, each of which is individually and specificallyincorporated by reference herein in its entirety fully as disclosed inthe aforementioned publication;

Ang2 specific antibodies, peptibodies, and related proteins, and thelike, including but not limited to those described in PCT PublicationNo. WO 03/057134 and U.S. Publication No. 2003/0229023, each of which isincorporated herein by reference in its entirety particularly in partspertinent to Ang2 specific antibodies and peptibodies and the like,especially those of sequences described therein and including but notlimited to: L1(N); L1(N) WT; L1(N) 1K WT; 2xL1(N); 2xL1(N) WT; Con4 (N),Con4 (N) 1K WT, 2xCon4 (N) 1K; L1C; L1C 1K; 2xL1C; Con4C; Con4C 1K;2xCon4C 1K; Con4-L1 (N); Con4-L1C; TN-12-9 (N); C17 (N); TN8-8(N);TN8-14 (N); Con 1 (N), also including anti-Ang 2 antibodies andformulations such as those described in PCT Publication No. WO2003/030833 which is incorporated herein by reference in its entirety asto the same, particularly Ab526; Ab528; Ab531; Ab533; Ab535; Ab536;Ab537; Ab540; Ab543; Ab544; Ab545; Ab546; A551; Ab553; Ab555; Ab558;Ab559; Ab565; AbF1AbFD; AbFE; AbFJ; AbFK; AbG1D4; AbGC1E8; AbH1C12;AbIA1; AbIF; AbIK, AbIP; and AbIP, in their various permutations asdescribed therein, each of which is individually and specificallyincorporated by reference herein in its entirety fully as disclosed inthe foregoing publication;

NGF specific antibodies, peptibodies, and related proteins, and the likeincluding, in particular, but not limited to those described in U.S.Publication No. 2005/0074821 and U.S. Pat. No. 6,919,426, which areincorporated herein by reference in their entirety particularly as toNGF-specific antibodies and related proteins in this regard, includingin particular, but not limited to, the NGF-specific antibodies thereindesignated 4D4, 4G6, 6H9, 7H2, 14D10 and 14D11, each of which isindividually and specifically incorporated by reference herein in itsentirety fully as disclosed in the foregoing publication;

CD22 specific antibodies, peptibodies, and related proteins, and thelike, such as those described in U.S. Pat. No. 5,789,554, which isincorporated herein by reference in its entirety as to CD22 specificantibodies and related proteins, particularly human CD22 specificantibodies, such as but not limited to humanized and fully humanantibodies, including but not limited to humanized and fully humanmonoclonal antibodies, particularly including but not limited to humanCD22 specific IgG antibodies, such as, for instance, a dimer of ahuman-mouse monoclonal hLL2 gamma-chain disulfide linked to ahuman-mouse monoclonal hLL2 kappa-chain, including, but limited to, forexample, the human CD22 specific fully humanized antibody inEpratuzumab, CAS registry number 501423-23-0;

IGF-1 receptor specific antibodies, peptibodies, and related proteins,and the like, such as those described in PCT Publication No. WO06/069202, which is incorporated herein by reference in its entirety asto IGF-1 receptor specific antibodies and related proteins, includingbut not limited to the IGF-1 specific antibodies therein designatedL1H1, L2H2, L3H3, L4H4, L5H5, L6H6, L7H7, L8H8, L9H9, L10H10, L11H11,L12H12, L13H13, L14H14, L15H15, L16H16, L17H17, L18H18, L19H19, L20H20,L21H21, L22H22, L23H23, L24H24, L25H25, L26H26, L27H27, L28H28, L29H29,L30H30, L31H31, L32H32, L33H33, L34H34, L35H35, L36H36, L37H37, L38H38,L39H39, L40H40, L41H41, L42H42, L43H43, L44H44, L45H45, L46H46, L47H47,L48H48, L49H49, L50H50, L51H51, L52H52, and IGF-1R-binding fragments andderivatives thereof, each of which is individually and specificallyincorporated by reference herein in its entirety fully as disclosed inthe foregoing publication;

Also among non-limiting examples of anti-IGF-1R antibodies for use inthe methods and compositions of the present invention are each and allof those described in:

(i) U.S. Publication No. 2006/0040358 (published Feb. 23, 2006),2005/0008642 (published Jan. 13, 2005), 2004/0228859 (published Nov. 18,2004), including but not limited to, for instance, antibody 1A (DSMZDeposit No. DSM ACC 2586), antibody 8 (DSMZ Deposit No. DSM ACC 2589),antibody 23 (DSMZ Deposit No. DSM ACC 2588) and antibody 18 as describedtherein;

(ii) PCT Publication No. WO 06/138729 (published Dec. 28, 2006) and WO05/016970 (published Feb. 24, 2005), and Lu et al. (2004), J. Biol.Chem. 279:2856-2865, including but not limited to antibodies 2F8, A12,and IMC-A12 as described therein;

(iii) PCT Publication No. WO 07/012614 (published Feb. 1, 2007), WO07/000328 (published Jan. 4, 2007), WO 06/013472 (published Feb. 9,2006), WO 05/058967 (published Jun. 30, 2005), and WO 03/059951(published Jul. 24, 2003);

(iv) U.S. Publication No. 2005/0084906 (published Apr. 21, 2005),including but not limited to antibody 7C10, chimaeric antibody C7C10,antibody h7C10, antibody 7H2M, chimaeric antibody *7C10, antibody GM607, humanized antibody 7C10 version 1, humanized antibody 7C10 version2, humanized antibody 7C10 version 3, and antibody 7H2HM, as describedtherein;

(v) U.S. Publication Nos. 2005/0249728 (published Nov. 10, 2005),2005/0186203 (published Aug. 25, 2005), 2004/0265307 (published Dec. 30,2004), and 2003/0235582 (published Dec. 25, 2003) and Maloney et al.(2003), Cancer Res. 63:5073-5083, including but not limited to antibodyEM164, resurfaced EM164, humanized EM164, huEM164 v1.0, huEM164 v1.1,huEM164 v1.2, and huEM164 v1.3 as described therein;

(vi) U.S. Pat. No. 7,037,498 (issued May 2, 2006), U.S. Publication Nos.2005/0244408 (published Nov. 30, 2005) and 2004/0086503 (published May6, 2004), and Cohen, et al. (2005), Clinical Cancer Res. 11:2063-2073,e.g., antibody CP-751,871, including but not limited to each of theantibodies produced by the hybridomas having the ATCC accession numbersPTA-2792, PTA-2788, PTA-2790, PTA-2791, PTA-2789, PTA-2793, andantibodies 2.12.1, 2.13.2, 2.14.3, 3.1.1, 4.9.2, and 4.17.3, asdescribed therein;

(vii) U.S. Publication Nos. 2005/0136063 (published Jun. 23, 2005) and2004/0018191 (published Jan. 29, 2004), including but not limited toantibody 19D12 and an antibody comprising a heavy chain encoded by apolynucleotide in plasmid 15H12/19D12 HCA (y4), deposited at the ATCCunder number PTA-5214, and a light chain encoded by a polynucleotide inplasmid 15H12/19D12 LCF (K), deposited at the ATCC under numberPTA-5220, as described therein; and

(viii) U.S. Publication No. 2004/0202655 (published Oct. 14, 2004),including but not limited to antibodies PINT-6A1, PINT-7A2, PINT-7A4,PINT-7A5, PINT-7A6, PINT-8A1, PINT-9A2, PINT-11A1, PINT-11A2, PINT-11A3,PINT-11A4, PINT- 11A5, PINT-11A7, PINT-11A12, PINT-12A1, PINT-12A2,PINT-12A3, PINT-12A4, and PINT-12A5, as described therein; each and allof which are herein incorporated by reference in their entireties,particularly as to the aforementioned antibodies, peptibodies, andrelated proteins and the like that target IGF-1 receptors;

B-7 related protein 1 specific antibodies, peptibodies, related proteinsand the like (“B7RP-1,” also is referred to in the literature as B7H2,ICOSL, B7h, and CD275), particularly B7RP-specific fully humanmonoclonal IgG2 antibodies, particularly fully human IgG2 monoclonalantibody that binds an epitope in the first immunoglobulin-like domainof B7RP-1, especially those that inhibit the interaction of B7RP-1 withits natural receptor, ICOS, on activated T cells in particular,especially, in all of the foregoing regards, those disclosed in U.S.Publication No. 2008/0166352 and PCT Publication No. WO 07/011941, whichare incorporated herein by reference in their entireties as to suchantibodies and related proteins, including but not limited to antibodiesdesignated therein as follow: 16H (having light chain variable and heavychain variable sequences SEQ ID NO:1 and SEQ ID NO:7 respectivelytherein); 5D (having light chain variable and heavy chain variablesequences SEQ ID NO:2 and SEQ ID NO:9 respectively therein); 2H (havinglight chain variable and heavy chain variable sequences SEQ ID NO:3 andSEQ ID NO:10 respectively therein); 43H (having light chain variable andheavy chain variable sequences SEQ ID NO:6 and SEQ ID NO:14 respectivelytherein); 41H (having light chain variable and heavy chain variablesequences SEQ ID NO:5 and SEQ ID NO:13 respectively therein); and 15H(having light chain variable and heavy chain variable sequences SEQ IDNO:4 and SEQ ID NO:12 respectively therein), each of which isindividually and specifically incorporated by reference herein in itsentirety fully as disclosed in the foregoing publication;

IL-15 specific antibodies, peptibodies, and related proteins, and thelike, such as, in particular, humanized monoclonal antibodies,particularly antibodies such as those disclosed in U.S. Publication Nos.2003/0138421; 2003/023586; and 2004/0071702; and U.S. Pat. No.7,153,507, each of which is incorporated herein by reference in itsentirety as to IL-15 specific antibodies and related proteins, includingpeptibodies, including particularly, for instance, but not limited to,HuMax IL-15 antibodies and related proteins, such as, for instance,146B7;

IFN gamma specific antibodies, peptibodies, and related proteins and thelike, especially human IFN gamma specific antibodies, particularly fullyhuman anti-IFN gamma antibodies, such as, for instance, those describedin U.S. Publication No. 2005/0004353, which is incorporated herein byreference in its entirety as to IFN gamma specific antibodies,particularly, for example, the antibodies therein designated 1118;1118*; 1119; 1121; and 1121*. The entire sequences of the heavy andlight chains of each of these antibodies, as well as the sequences oftheir heavy and light chain variable regions and complementaritydetermining regions, are each individually and specifically incorporatedby reference herein in its entirety fully as disclosed in the foregoingpublication and in Thakur et al. (1999), Mol. Immunol. 36:1107-1115. Inaddition, description of the properties of these antibodies provided inthe foregoing publication is also incorporated by reference herein inits entirety. Specific antibodies include those having the heavy chainof SEQ ID NO:17 and the light chain of SEQ ID NO:18; those having theheavy chain variable region of SEQ ID NO:6 and the light chain variableregion of SEQ ID NO:8; those having the heavy chain of SEQ ID NO:19 andthe light chain of SEQ ID NO:20; those having the heavy chain variableregion of SEQ ID NO:10 and the light chain variable region of SEQ IDNO:12; those having the heavy chain of SEQ ID NO:32 and the light chainof SEQ ID NO:20; those having the heavy chain variable region of SEQ IDNO:30 and the light chain variable region of SEQ ID NO:12; those havingthe heavy chain sequence of SEQ ID NO:21 and the light chain sequence ofSEQ ID NO:22; those having the heavy chain variable region of SEQ IDNO:14 and the light chain variable region of SEQ ID NO:16; those havingthe heavy chain of SEQ ID NO:21 and the light chain of SEQ ID NO:33; andthose having the heavy chain variable region of SEQ ID NO:14 and thelight chain variable region of SEQ ID NO:31, as disclosed in theforegoing publication. A specific antibody contemplated is antibody 1119as disclosed in the foregoing U.S. publication and having a completeheavy chain of SEQ ID NO:17 as disclosed therein and having a completelight chain of SEQ ID NO:18 as disclosed therein;

TALL-1 specific antibodies, peptibodies, and the related proteins, andthe like, and other TALL specific binding proteins, such as thosedescribed in U.S. Publication Nos. 2003/0195156 and 2006/0135431, eachof which is incorporated herein by reference in its entirety as toTALL-1 binding proteins, particularly the molecules of Tables 4 and 5B,each of which is individually and specifically incorporated by referenceherein in its entirety fully as disclosed in the foregoing publications;

Parathyroid hormone (“PTH”) specific antibodies, peptibodies, andrelated proteins, and the like, such as those described in U.S. Pat. No.6,756,480, which is incorporated herein by reference in its entirety,particularly in parts pertinent to proteins that bind PTH;

Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, andrelated proteins, and the like, such as those described in U.S. Pat. No.6,835,809, which is herein incorporated by reference in its entirety,particularly in parts pertinent to proteins that bind TPO-R;

Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, andrelated proteins, and the like, including those that target theHGF/SF:cMet axis (HGF/SF:c-Met), such as the fully human monoclonalantibodies that neutralize hepatocyte growth factor/scatter (HGF/SF)described in U.S. Publication No. 2005/0118643 and PCT Publication No.WO 2005/017107, huL2G7 described in U.S. Pat. No. 7,220,410 and OA-5d5described in U.S. Pat. Nos. 5,686,292 and 6,468,529 and in PCTPublication No. WO 96/38557, each of which is incorporated herein byreference in its entirety, particularly in parts pertinent to proteinsthat bind HGF;

TRAIL-R2 specific antibodies, peptibodies, related proteins and thelike, such as those described in U.S. Pat. No. 7,521,048, which isherein incorporated by reference in its entirety, particularly in partspertinent to proteins that bind TRAIL-R2;

Activin A specific antibodies, peptibodies, related proteins, and thelike, including but not limited to those described in U.S. PublicationNo. 2009/0234106, which is herein incorporated by reference in itsentirety, particularly in parts pertinent to proteins that bind ActivinA;

TGF-beta specific antibodies, peptibodies, related proteins, and thelike, including but not limited to those described in U.S. Pat. No.6,803,453 and U.S. Publication No. 2007/0110747, each of which is hereinincorporated by reference in its entirety, particularly in partspertinent to proteins that bind TGF-beta;

Amyloid-beta protein specific antibodies, peptibodies, related proteins,and the like, including but not limited to those described in PCTPublication No. WO 2006/081171, which is herein incorporated byreference in its entirety, particularly in parts pertinent to proteinsthat bind amyloid-beta proteins. One antibody contemplated is anantibody having a heavy chain variable region comprising SEQ ID NO:8 anda light chain variable region having SEQ ID NO:6 as disclosed in theforegoing publication;

c-Kit specific antibodies, peptibodies, related proteins, and the like,including but not limited to those described in U.S. Publication No.2007/0253951, which is incorporated herein by reference in its entirety,particularly in parts pertinent to proteins that bind c-Kit and/or otherstem cell factor receptors;

OX40L specific antibodies, peptibodies, related proteins, and the like,including but not limited to those described in U.S. Publication No.2006/0002929, which is incorporated herein by reference in its entirety,particularly in parts pertinent to proteins that bind OX40L and/or otherligands of the OX40 receptor; and

Other exemplary proteins, including Activase® (alteplase, tPA); Aranesp®(darbepoetin alfa); Epogen® (epoetin alfa, or erythropoietin); GLP-1,Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonalantibody); Betaseron® (interferon-beta); Campath® (alemtuzumab,anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade®(bortezomib); MLN0002 (anti-α4ß7 mAb); MLN1202 (anti-CCR2 chemokinereceptor mAb); Enbrel® (etanercept, TNF-receptor/Fc fusion protein, TNFblocker); Eprex® (epoetin alfa); Erbitux® (cetuximab,anti-EGFR/HER1/c-ErbB-1); Genotropin® (somatropin, Human GrowthHormone); Herceptin® (trastuzumab, anti-HER2/neu (erbB2) receptor mAb);Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab);insulin in solution; Infergen® (interferon alfacon-1); Natrecor®(nesiritide; recombinant human B-type natriuretic peptide (hBNP);Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide®(epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab,anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin);Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™(eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524);Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio®(lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4);Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumabmertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega®(oprelvekin, human interleukin-11); Neulasta® (pegylated filgastrim,pegylated G-CSF, pegylated hu-Met-G-CSF); Neupogen® (filgrastim, G-CSF,hu-MetG-CSF); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonalantibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFαmonoclonal antibody); Reopro® (abciximab, anti-GP Ilb/Ilia receptormonoclonal antibody); Actemra® (anti-IL6 Receptor mAb); Avastin®(bevacizumab), HuMax-CD4 (zanolimumab); Rituxan® (rituximab, anti-CD20mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect®(basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 146B7-CHO(anti-IL15 antibody, see U.S. Pat. No. 7,153,507); Tysabri®(natalizumab, anti-α4integrin mAb); Valortim® (MDX-1303, anti-B.anthracis protective antigen mAb); ABthrax™; Vectibix® (panitumumab);Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portionof human IgG1 and the extracellular domains of both IL-1 receptorcomponents (the Type I receptor and receptor accessory protein)); VEGFtrap (Ig domains of VEGFR1 fused to IgG1 Fc); Zenapax® (daclizumab);Zenapax® (daclizumab, anti-IL-2Ra mAb); Zevalin® (ibritumomab tiuxetan);Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonalantibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3/huFcfusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFαmAb); HGS-ETR1 (mapatumumab; human anti-TRAIL Receptor-1 mAb);HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab);M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab,anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-C. difficileToxin A and Toxin B C mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC);anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333(anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD4OL mAb; anti-CriptomAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019);anti-CTLA4 mAb; anti-eotaxinl mAb (CAT-213); anti-FGF8 mAb;anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb(MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMaxHepC); anti-IFNαmAb (MEDI-545, MDX-1103); anti-IGF1R mAb; anti-IGF-1RmAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12/IL23 mAb (CNTO1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10Ulcerative Colitis mAb (MDX-1100); anti-LLY antibody; BMS-66513;anti-Mannose Receptor/hCGβmAb (MDX-1307); anti-mesothelin dsFv-PE38conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRaantibody (IMC-3G3); anti-TGFßmAb (GC-1008); anti-TRAIL Receptor-2 humanmAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR/Flt-1 mAb; anti-ZP3 mAb(HuMax-ZP3); NVS Antibody #1; and NVS Antibody #2.

Also included can be a sclerostin antibody, such as but not limited toromosozumab, blosozumab, or BPS 804 (Novartis). Further included can betherapeutics such as rilotumumab, bixalomer, trebananib, ganitumab,conatumumab, motesanib diphosphate, brodalumab, vidupiprant,panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX or XGEVA. Additionally,included in the device can be a monoclonal antibody (IgG) that bindshuman Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9), e.g. U.S.Pat. No. 8,030,547, U.S. Publication No. 2013/0064825, WO2008/057457,WO2008/057458, WO2008/057459, WO2008/063382, WO2008/133647,WO2009/100297, WO2009/100318, WO2011/037791, WO2011/053759,WO2011/053783, WO2008/125623, WO2011/072263, WO2009/055783,WO2012/0544438, WO2010/029513, WO2011/111007, WO2010/077854,WO2012/088313, WO2012/101251, WO2012/101252, WO2012/101253,WO2012/109530, and WO2001/031007.

Also included can be talimogene laherparepvec or another oncolytic HSVfor the treatment of melanoma or other cancers. Examples of oncolyticHSV include, but are not limited to talimogene laherparepvec (U.S. Pat.Nos. 7,223,593 and 7,537,924); OncoVEXGALV/CD (U.S. Pat. No. 7,981,669);OrienX010 (Lei et al. (2013), World J. Gastroenterol., 19:5138-5143);G207, 1716; NV1020; NV12023; NV1034 and NV1042 (Vargehes et al. (2002),Cancer Gene Ther., 9(12):967-978).

Also included are TIMPs. TIMPs are endogenous tissue inhibitors ofmetalloproteinases (TIMPs) and are important in many natural processes.TIMP-3 is expressed by various cells or and is present in theextracellular matrix; it inhibits all the major cartilage-degradingmetalloproteases, and may play a role in role in many degradativediseases of connective tissue, including rheumatoid arthritis andosteoarthritis, as well as in cancer and cardiovascular conditions. Theamino acid sequence of TIMP-3, and the nucleic acid sequence of a DNAthat encodes TIMP-3, are disclosed in U.S. Pat. No. 6,562,596, issuedMay 13, 2003, the disclosure of which is incorporated by referenceherein. Description of TIMP mutations can be found in U.S. PublicationNo. 2014/0274874 and PCT Publication No. WO 2014/152012.

Also included are antagonistic antibodies for human calcitoningene-related peptide (CGRP) receptor and bispecific antibody moleculethat target the CGRP receptor and other headache targets. Furtherinformation concerning these molecules can be found in PCT ApplicationNo. WO 2010/075238.

Additionally, a bispecific T cell engager antibody (BiTe), e.g.Blinotumomab can be used in the device. Alternatively, included can bean APJ large molecule agonist e.g., apelin or analogues thereof in thedevice. Information relating to such molecules can be found in PCTPublication No. WO 2014/099984.

In certain embodiments, the medicament comprises a therapeuticallyeffective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLPreceptor antibody. Examples of anti-TSLP antibodies that may be used insuch embodiments include, but are not limited to, those described inU.S. Pat. Nos. 7,982,016, and 8,232,372, and U.S. Publication No.2009/0186022. Examples of anti-TSLP receptor antibodies include, but arenot limited to, those described in U.S. Pat. No. 8,101,182. Inparticularly preferred embodiments, the medicament comprises atherapeutically effective amount of the anti-TSLP antibody designated asA5 within U.S. Pat. No. 7,982,016.

Although the drug delivery device, insertion mechanisms, drivemechanisms, systems, methods, and elements thereof, have been describedin terms of exemplary embodiments, they are not limited thereto. Thedetailed description is to be construed as exemplary only and does notdescribe every possible embodiment of the invention because describingevery possible embodiment would be impractical, if not impossible.Numerous alternative embodiments could be implemented, using eithercurrent technology or technology developed after the filing date of thispatent that would still fall within the scope of the claims defining theinvention.

It should be understood that the legal scope of the invention is definedby the words of the claims set forth at the end of this patent. Theappended claims should be construed broadly to include other variantsand embodiments of same, which may be made by those skilled in the artwithout departing from the scope and range of equivalents of the device,drive mechanisms, systems, methods, and their elements.

What is claimed:
 1. A wearable drug delivery device comprising: ahousing; a drug storage container positioned at least partially withinthe housing; and an insertion mechanism positioned at least partiallywithin the housing and including: a delivery member connected orconfigured to be connected in fluid communication with the drug storagecontainer, the delivery member being moveable between a first positionwherein an insertion portion of the delivery member is positioned withinthe housing and a second position wherein the insertion portion of thedelivery member is positioned exterior to the housing for insertion intoa patient, a hub operably coupled with the delivery member, a powersource configured to generate rotational motion, and a motion conversionmechanism operably coupled with the power source and the hub, the motionconversion mechanism being configured to convert the rotational motionof the power source into linear motion of the hub to move the deliverymember between the first position and the second position, whereinoperation of the power source causes at least a portion of the motionconversion mechanism to rotate about a rotational axis, the rotationalaxis being substantially stationary with respect to the housing duringrotation of the at least a portion of the motion conversion mechanism,the at least a portion of the motion conversion mechanism slidablyengaging at least a portion of the hub during rotation of the at least aportion of the motion conversion mechanism.
 2. The wearable drugdelivery device of claim 1, comprising at least one fluid conduitconfigured to fluidly connect the delivery member and the drug storagecontainer, the at least one fluid conduit being coupled to the hub suchthat at least a portion of the fluid conduit and the hub translatejointly during insertion of the delivery member into the patient.
 3. Thewearable drug delivery device of claim 1, wherein the delivery memberincludes a hollow needle.
 4. The wearable drug delivery device of claim1, wherein the delivery member includes a solid trocar.
 5. The wearabledrug delivery device of claim 1, wherein, the hub, in moving from thefirst position to the second position, moves with respect to therotational axis.
 6. The wearable drug delivery device of claim 1,comprising an adhesive applied to an exterior wall of the housing forattaching the housing to skin of a patient.
 7. The wearable drugdelivery device of claim 6, comprising an opening formed in the exteriorwall of the housing, wherein the insertion portion of the deliverymember extends through the opening in the second position.
 8. Thewearable drug delivery device of claim 1, wherein the at least a portionof the motion conversion mechanism includes a rotatable member operablycoupled to the hub and rotatable about the rotational axis by the powersource.
 9. The wearable drug delivery device of claim 8, wherein therotational axis is traverse to a longitudinal axis of the deliverymember.
 10. The wearable drug delivery device of claim 8, whereininitial rotation of the rotatable member causes the delivery member totranslate from the first position to the second position and subsequentrotation of the rotatable member causes the delivery member to translatefrom the second position to the first position.
 11. The wearable drugdelivery device of claim 8, wherein the motion conversion mechanismincludes a slot and a connector member slidably received in the slot,wherein rotation of the rotatable member causes the connector member toslide along a wall defining the slot.
 12. The wearable drug deliverydevice of claim 11, wherein the connector member is a pin fixed to therotatable member.
 13. The wearable drug delivery device of claim 8,wherein the power source includes a torsion spring.
 14. The wearabledrug delivery device of claim 13, wherein at least a portion of thetorsion spring is exterior to the rotatable member.
 15. A methodcomprising: providing a wearable drug delivery device comprising ahousing, a drug storage container positioned at least partially withinthe housing, and an insertion mechanism, the insertion mechanismincluding a delivery member, a hub operably coupled with the deliverymember, a power source configured to generate rotational motion, and amotion conversion mechanism configured to convert the rotational motionof the power source into linear motion of the hub; positioning thehousing in contact with a patient; activating the power source to rotateat least a portion of the motion conversion mechanism about a rotationalaxis to move the delivery member linearly from a first position whereinan insertion portion of the delivery member is positioned within thehousing to a second position wherein the insertion portion of thedelivery member is inserted into the patient, wherein the rotationalaxis is substantially stationary with respect to the housing duringrotation of the at least a portion of the motion conversion mechanism,the at least a portion of the motion conversion mechanism slidablyengaging at least a portion of the hub during rotation of the at least aportion of the motion conversion mechanism; and moving a drug out of thedrug storage container into the patient via the delivery member.
 16. Themethod of claim 15, wherein the delivery member includes a hollowneedle.
 17. The method of claim 15, wherein positioning the housing incontact with the patient comprises adhering the housing to skin of thepatient.
 18. The method of claim 15, wherein, the hub, in moving fromthe first position to the second position, moves with respect to therotational axis.
 19. The method of claim 15, wherein the at least aportion of the motion conversion mechanism comprises a rotatable memberoperably coupled to the hub and rotatable about the rotational axis bythe power source.
 20. The method of claim 19, comprising, after movingthe delivery member from the first position to the second position,rotating the rotatable member such that the motion conversion mechanismtranslates the delivery member from the second position to the firstposition.
 21. A wearable drug delivery device comprising: a housing; adrug storage container positioned at least partially within the housing;and an insertion mechanism positioned at least partially within thehousing and including: a delivery member connected or configured to beconnected in fluid communication with the drug storage container, thedelivery member being moveable between a first position wherein aninsertion portion of the delivery member is positioned within thehousing and a second position wherein the insertion portion of thedelivery member is positioned exterior to the housing for insertion intoa patient, a hub operably coupled with the delivery member, a powersource configured to generate rotational motion, and a motion conversionmechanism operably coupled with the power source and the hub, the motionconversion mechanism being configured to convert the rotational motionof the power source into linear motion of the hub to move the deliverymember between the first position and the second position, whereinoperation of the power source causes at least a portion of the motionconversion mechanism to rotate about a rotational axis, the rotationalaxis being substantially stationary with respect to the housing duringrotation of the at least a portion of the motion conversion mechanism,and wherein the motion conversion mechanism comprises a rotatable memberconfigured to: (i) rotate in a first rotational direction to move thedelivery member from the first position to the second position, and (ii)further rotate in the first rotational direction to move the deliverymember from the second position to the first position.
 22. A methodcomprising: providing a wearable drug delivery device comprising ahousing, a drug storage container positioned at least partially withinthe housing, and an insertion mechanism, the insertion mechanismincluding a delivery member, a hub operably coupled with the deliverymember, a power source configured to generate rotational motion, and amotion conversion mechanism configured to convert the rotational motionof the power source into linear motion of the hub; positioning thehousing in contact with a patient; activating the power source to rotateat least a portion of the motion conversion mechanism about a rotationalaxis to move the delivery member linearly from a first position whereinan insertion portion of the delivery member is positioned within thehousing to a second position wherein the insertion portion of thedelivery member is inserted into the patient, wherein the rotationalaxis is substantially stationary with respect to the housing duringrotation of the at least a portion of the motion conversion mechanism;moving a drug out of the drug storage container into the patient via thedelivery member; and rotating the at least a portion of the motionconversion mechanism about the rotational axis to move the deliverymember linearly from the second position to the first position, whereinthe at least a portion of the motion conversion mechanism rotates in afirst rotational direction when moving the delivery member linearly fromthe first position to the second position and rotates in the firstrotational direction when moving the delivery member from the secondposition to the first position.